Informations générales (source: ClinicalTrials.gov)
Electrophysiology of Brain Activity During Electrode Implantation in Patients Treated With Deep Brain Stimulation (LFP-DBS)
Interventional
N/A
University Hospital, Grenoble (Voir sur ClinicalTrials)
avril 2011
mars 2021
29 juin 2024
Primary objective
Demonstrate functional markers derived from electrophysiological signals recorded during
cognitive tests. These markers should make it possible to optimize the targeting
procedures of electrode implantation sites for a better effectiveness of deep brain
stimulation therapy.
Research hypotheses
The mechanisms of action of the deep brain stimulation (DBS) involve the modulation of
the activity, locally and on a large scale, of functional cortical-subcortical networks
showing pathological behavior beforehand. The electrophysiological measurements in
response to different tasks make it possible to highlight precise dysfunctions of these
neural networks, in relation with the behavioral and / or motor disorders associated with
the pathologies treated by DBS.
Consequently, we hypothesize that the exploitation of electrophysiological responses
during cognitive or sensorimotor tasks performed during the implantation procedure of
stimulation electrodes in patients treated with DBS will allow :
- To collect fundamental data to understanding the physiological functioning of basal
ganglia in humans ;
- To collect functional markers from the operating room in relation to the symptoms
targeted by the DBS that will help in the choice of implantation site of the
stimulation electrode ;
- Define long-term predictive markers of DBS effects by comparing electrophysiological
effects measured post-operatively and clinical scores under DBS.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Grenoble-Alpes - Grenoble - France | Stephan CHABARDES, Pr | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Pathology requiring brain stimulation therapy (criteria of severity, therapeutic
resistance and severity of disability): motor disorders (eg Parkinson's disease,
dystonia) or psychiatric disorders (eg OCD, depression).
- These pathologies therefore include motor disorders (eg Parkinson's disease,
dystonia) or psychiatric disorders that can be treated with brain stimulation
therapy. Note that these are independent of motor disorders. The inclusion criteria
obviously depend on the pathology.
As an example for a motor pathology treated by stimulation, in Parkinson's disease the
following inclusion criteria are used :
- patients aged 18 to 75 and affiliated to a social security scheme
- Idiopathic Parkinson's disease that meets the United Kingdom Parkinson's Disease
Brain Bank (UKPDSBB) criteria or suffering from recessive autosomal juvenile
parkinsonism
- duration of evolution of the disease> 5 years
- stage of severe motor complications of levodopa despite optimal treatment.
For dystonic patients, the following inclusion criteria are used :
- Disabling dystonia (severe focal, segmental or generalized).
- Patient ≥ 18 years of age and under age 65
- Duration of evolution of dystonia greater than one year.
For patients with obsessive-compulsive disorder (OCD), the following inclusion criteria
are used :
- OCD which has been diagnosed for at least 5 years according to the DSM-IV criteria
as OCD with "good insight", confirmed using the Diagnostic Interview Genetic Study
(DIGS) - OCD section ; score below the delusional idea threshold at the BABS (Brown
Assessment of Beliefs Scale) insight scale (Eisen, Phillips et al., 1998)
- OCD of severe intensity (total YBOCS > 25, or subscale Obsessions or Compulsions >
15, EGF < 40, CGI > 4) with prognosis considered to be bad in the absence of
intervention
- Non-responder OCD (an improvement of less than 25% on the Y-BOCS scale) to at least
three IRS-type antidepressants, including clomipramine, used sequentially at the
maximum tolerated dose for at least 12 weeks. Used alone and in combination for at
least 1 month with risperidone or pimozide and any of the following products :
lithium salts or clonazepam or buspirone or pindolol (Greist and Jefferson 1998)
(McDougle, Epperson et al 2000) (Dannon , Sasson et al., 2000)
- OCD having benefited from Behavioral and Cognitive Therapy for at least 1 year
(application of classical programs, including exposure techniques with prevention of
ritualized response, with at least two sessions per month).
- Patient between 18 and 60 years of age who has given his signature and informed
consent after receiving written information on the proposed procedure
- Sick with social security
For patients with depressive illness, the following inclusion criteria were used :
- male or female between the ages of 30 and 65
- with a diagnosis of unipolar major depression (MINI) resistant to conventional
treatments
- Hamilton and Montgomery Depression Scale (HAMD) score> 20
- Duration of the current depressive episode of more than 12 months, the patient being
included in a care system has established the chronic and recurrent state of this
depression,
- Ineffective treatment of the current episode with at least 4 therapeutic attempts
including antidepressant drug monotherapy treatments (MAOIs, tricyclic
antidepressants, selective serotonin reuptake inhibitors, mixed serotonin reuptake
inhibitors, and norepinephrine), the potentiations of antidepressant treatments (by
lithium salts, thyroid hormones or neuroleptics), the psychotherapies structured
according to validated techniques, the ECT carried out under conditions in
conformity with the recommendations (ANAES, 1998) (at least 6 sessions in technical
bilateral with control of duration of seizure)
- Women of childbearing age should follow a contraceptive method that is
considered sufficiently effective by the investigator. In this case a pregnancy
test will be performed on inclusion
- outpatient or inpatient
- fluent in the French language and able to understand the procedures of the
study and in particular complete the self-questionnaires used
- Patient likely to give informed consent
- Patient affiliated with Social Security
- Patient's written agreement to participate in the study
- Intellectual abilities compatible with cognitive or motor tasks
- Pathology requiring brain stimulation therapy (criteria of severity, therapeutic
resistance and severity of disability): motor disorders (eg Parkinson's disease,
dystonia) or psychiatric disorders (eg OCD, depression).
- These pathologies therefore include motor disorders (eg Parkinson's disease,
dystonia) or psychiatric disorders that can be treated with brain stimulation
therapy. Note that these are independent of motor disorders. The inclusion criteria
obviously depend on the pathology.
As an example for a motor pathology treated by stimulation, in Parkinson's disease the
following inclusion criteria are used :
- patients aged 18 to 75 and affiliated to a social security scheme
- Idiopathic Parkinson's disease that meets the United Kingdom Parkinson's Disease
Brain Bank (UKPDSBB) criteria or suffering from recessive autosomal juvenile
parkinsonism
- duration of evolution of the disease> 5 years
- stage of severe motor complications of levodopa despite optimal treatment.
For dystonic patients, the following inclusion criteria are used :
- Disabling dystonia (severe focal, segmental or generalized).
- Patient ≥ 18 years of age and under age 65
- Duration of evolution of dystonia greater than one year.
For patients with obsessive-compulsive disorder (OCD), the following inclusion criteria
are used :
- OCD which has been diagnosed for at least 5 years according to the DSM-IV criteria
as OCD with "good insight", confirmed using the Diagnostic Interview Genetic Study
(DIGS) - OCD section ; score below the delusional idea threshold at the BABS (Brown
Assessment of Beliefs Scale) insight scale (Eisen, Phillips et al., 1998)
- OCD of severe intensity (total YBOCS > 25, or subscale Obsessions or Compulsions >
15, EGF < 40, CGI > 4) with prognosis considered to be bad in the absence of
intervention
- Non-responder OCD (an improvement of less than 25% on the Y-BOCS scale) to at least
three IRS-type antidepressants, including clomipramine, used sequentially at the
maximum tolerated dose for at least 12 weeks. Used alone and in combination for at
least 1 month with risperidone or pimozide and any of the following products :
lithium salts or clonazepam or buspirone or pindolol (Greist and Jefferson 1998)
(McDougle, Epperson et al 2000) (Dannon , Sasson et al., 2000)
- OCD having benefited from Behavioral and Cognitive Therapy for at least 1 year
(application of classical programs, including exposure techniques with prevention of
ritualized response, with at least two sessions per month).
- Patient between 18 and 60 years of age who has given his signature and informed
consent after receiving written information on the proposed procedure
- Sick with social security
For patients with depressive illness, the following inclusion criteria were used :
- male or female between the ages of 30 and 65
- with a diagnosis of unipolar major depression (MINI) resistant to conventional
treatments
- Hamilton and Montgomery Depression Scale (HAMD) score> 20
- Duration of the current depressive episode of more than 12 months, the patient being
included in a care system has established the chronic and recurrent state of this
depression,
- Ineffective treatment of the current episode with at least 4 therapeutic attempts
including antidepressant drug monotherapy treatments (MAOIs, tricyclic
antidepressants, selective serotonin reuptake inhibitors, mixed serotonin reuptake
inhibitors, and norepinephrine), the potentiations of antidepressant treatments (by
lithium salts, thyroid hormones or neuroleptics), the psychotherapies structured
according to validated techniques, the ECT carried out under conditions in
conformity with the recommendations (ANAES, 1998) (at least 6 sessions in technical
bilateral with control of duration of seizure)
- Women of childbearing age should follow a contraceptive method that is
considered sufficiently effective by the investigator. In this case a pregnancy
test will be performed on inclusion
- outpatient or inpatient
- fluent in the French language and able to understand the procedures of the
study and in particular complete the self-questionnaires used
- Patient likely to give informed consent
- Patient affiliated with Social Security
- Patient's written agreement to participate in the study
- Intellectual abilities compatible with cognitive or motor tasks
- Persons referred to in Articles L1121-5 to L1121-8 of the CSP.